NCT01294436

Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus

A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 728 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.

Conditions

• Type2 Diabetes
• High Blood Sugar

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Oral Dose 5 or 10 mg

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-02-11
• Last updated: 2013-12-17
• Results posted: 2013-09-16

Locations

38 sites across 1 country: Japan